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LEVITRA Drug Profile

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Which patents cover Levitra, and what substitute generic drugs are available?

Levitra is a drug marketed by Bayer Hlthcare and is included in one NDA. There are four patents protecting this drug and three Paragraph IV challenges.

This drug has one hundred and twenty-seven patent family members in fifty-two countries.

The generic ingredient in LEVITRA is vardenafil hydrochloride. There are five drug master file entries for this compound. Six suppliers are listed for this compound. There are three tentative approvals for this compound. Additional details are available on the vardenafil hydrochloride profile page.

Summary for Tradename: LEVITRA

Patents:4
Applicants:1
NDAs:1
Suppliers / Packagers: see list6
Bulk Api Vendors: see list49
Clinical Trials: see list8
Patent Applications: see list1,799
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:LEVITRA at DailyMed

Pharmacology for Tradename: LEVITRA

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bayer Hlthcare
LEVITRA
vardenafil hydrochloride
TABLET;ORAL021400-003Aug 19, 2003RXYesNo6,362,178► SubscribeYY ► Subscribe
Bayer Hlthcare
LEVITRA
vardenafil hydrochloride
TABLET;ORAL021400-001Aug 19, 2003RXYesNo8,273,876► Subscribe ► Subscribe
Bayer Hlthcare
LEVITRA
vardenafil hydrochloride
TABLET;ORAL021400-003Aug 19, 2003RXYesNo8,841,446► SubscribeY ► Subscribe
Bayer Hlthcare
LEVITRA
vardenafil hydrochloride
TABLET;ORAL021400-002Aug 19, 2003RXYesNo8,841,446► SubscribeY ► Subscribe
Bayer Hlthcare
LEVITRA
vardenafil hydrochloride
TABLET;ORAL021400-001Aug 19, 2003RXYesNo8,841,446► SubscribeY ► Subscribe
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Paragraph IV activity for: LEVITRA

Drugname Dosage Strength RLD Submissiondate
vardenafil hydrochlorideTablets2.5 mgLevitra9/4/2009
vardenafilTablets5 mg ad 10 mgLevitra7/10/2009
vardenafil hydrochlorideTablets20 mgLevitra3/5/2009

Non-Orange Book Patents for Tradename: LEVITRA

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,566,360 2-phenyl substituted imidatriazinones as phosphodiesterase inhibitors► Subscribe
7,704,9992-phenyl substituted imidazotriazinones as phosphodiesterase inhibitors► Subscribe
7,314,8712-phenyl substituted imidazotriazinones as phosphodiesterase inhibitors, for treatment of hypertension► Subscribe
6,890,922 2-phenyl substituted imidazotriazinones as phosphodiesterase inhibitors► Subscribe
7,122,5402-Phenyl substituted imidazotriazinones as phosphodiesterase inhibitors► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: LEVITRA

Country Document Number Estimated Expiration
Spain2386420► Subscribe
Portugal1523303► Subscribe
Czech Republic20001759► Subscribe
TaiwanI229081► Subscribe
Slovakia7092000► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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